Post-Traumatic Osteoarthritis of AnkleNCT03711747
Indications for Osteochondral Allograft Transplantation
An observational study of Post-Traumatic Osteoarthritis of Ankle and Ankle Osteoarthritis, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
With IRB approval, a prospective single-cohort clinical trial will be performed to assess safety and efficacy of total biologic arthroplasty of the ankle. With informed consent, patients (n=10) who require tibio-talar arthroplasty based on physical examination and diagnostic imaging will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Post-Traumatic Osteoarthritis of Ankle, Ankle Osteoarthritis, Ankle Injuries
- What is being tested?
- Osteochondral allograft ankle
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: With informed consent, patients (n=10) who require tibio-talar arthroplasty based on physical examination and diagnostic imaging will be enrolled. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the tibial plafond and/or talar dome as determined by physical examination, diagnostic imaging and/or arthroscopy by the attending surgeon. Exclusion criteria include acute injury to any other part of the affected lower extremity or inability to comply with the protocol.
Who may be able to join
- Grade IV changes in the articular cartilage of the tibial plafond and/or talar dome as determined by physical exam, diagnostic imaging, and/or arthroscopy by the attending surgeon ii. Between the age of 18-55
Who cannot join
- Acute injury to any other part of the affected lower extremity ii. Inability to comply with protocol iii. BMI greater than 40 iv. The subject is either pregnant or a prisoner v. Currently involved in worker's compensation case at the time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Orthopaedic Institute
Columbia, Missouri, 65202
About this study
Official title: Indications for Osteochondral Allograft Transplantation by Evaluating Safety and Efficacy of Total Biologic Total Joint Replacement of Ankle Post-traumatic Osteoarthritis (PTOA)
With IRB approval, a prospective single-cohort clinical trial will be performed to assess safety and efficacy of total biologic arthroplasty of the ankle. With informed consent, patients (n=10) who require tibio-talar arthroplasty based on physical examination and diagnostic imaging will be enrolled. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the tibial plafond and/or talar dome as determined by physical examination, diagnostic imaging and/or arthroscopy by the attending surgeon. Exclusion criteria include acute injury to any other part of the affected lower extremity or inability to comply with the protocol.
After enrollment, patients will undergo standard ankle radiography and complete assessments (described below). Size-matched (standard clinical methodology) MOPSTM allografts (Musculoskeletal Transplant Foundation, Edison, NJ) from the same donor will be obtained to treat the entire tibiotalar joint. The affected joint will be treated with OCA transplants using our current technique and instrumentation. Osteochondral grafts including MOPSTM OCAs are regulated under U.S. Food and Drug Administration (FDA) section 361 of the Public Health Service Act and 21 Code of Federal Regulation 1271 that defines human cells, tissues or cellular or tissue based products (HCT/P).
Read more
Patients will follow a managed post-operative rehabilitation protocol that is standard for those that have had an osteochondral allograft to their ankle.
Range of motion and patient-reported outcome measures (PROMs) including VAS pain score, AOFAS, and PROMIS Mobility as well as complete radiographs (XR) of the affected ankle will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery to evaluate healing, function and evidence for arthrosis. MRIs for cartilage composition (12 months after surgery, and serum and urine biomarkers for treatment monitoring (preop, 6 and 12 months after surgery) will be performed. We will document all adverse events and complications, including joint or incision infection, graft failure, hardware failure, and arthrofibrosis. Patients with a VAS pain score >5 beyond 3 months postoperatively or clinical or diagnostic imaging evidence for nonunion or graft collapse will undergo MRI of the ankle to determine the appropriate clinical course of action. OCA survival will be determined based on maintenance of acceptable levels of pain (<2 VAS) and function and/or need for revision surgery or total ankle arthroplasty, fusion, or amputation.
- Being tested
- Osteochondral allograft ankle
- Keywords
- Ankle, Ankle Pain, Joint Pain, Ankle Osteoarthritis
- Medical subject headings
- Ankle Injuries, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteochondral allograft ankleProcedure or surgery
Open osteochondral allograft to replace the cartilage that is grade four on the tibia and/or talus
| Study group | Role | What they receive |
|---|---|---|
| Post-traumatic Ankle OA | Post-traumatic ankle OA and requiring osteochondral allograft to tibia and/or talus in ankle Receives: Procedure: Osteochondral allograft ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) score
Pain assessment which measures what a patient rates their pain between 0 and 10, with 0 being no pain, and 10 being the most pain
Measured: 12 Months
Secondary outcomes (2)
American Orthopaedic Foot and Ankle Society (AOFAS) score
This measurement tool measures a patient's function out of 100, with 100 being highest amount of function
Measured: 12 Months
PROMIS - Physical Function and Mobility
A survey related to physical function and mobility
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Jan 2019
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Osteoarthritis of AnkleStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Stannard, University of Missouri-Columbia
- Investigators
- James Stannard, MD, Principal investigator, University of Missouri, Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711747
- Sponsor's protocol ID
- 2011144
- Status last verified
- Nov 2022
- First submitted
- 16 Oct 2018
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indications for Osteochondral Allograft Transplantation by Evaluating Safety and Efficacy of Total Biologic Total Joint Replacement of Ankle Post-traumatic Osteoarthritis (PTOA)
- ClinicalTrials.gov ID
- NCT03711747
- Acronym / sponsor ID
- 2011144
- Keywords
- Ankle, Ankle Pain, Joint Pain, Ankle Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With IRB approval, a prospective single-cohort clinical trial will be performed to assess safety and efficacy of total biologic arthroplasty of the ankle. With informed consent, patients (n=10) who require tibio-talar arthroplasty based on physical examination and diagnostic imaging will be enrolled. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the tibial plafond and/or talar dome as determined by physical examination, diagnostic imaging and/or arthroscopy by the attending surgeon. Exclusion criteria include acute injury to any other part of the affected lower extremity or inability to comply with the protocol.
After enrollment, patients will undergo standard ankle radiography and complete assessments (described below). Size-matched (standard clinical methodology) MOPSTM allografts (Musculoskeletal Transplant Foundation, Edison, NJ) from the same donor will be obtained to treat the entire tibiotalar joint. The affected joint will be treated with OCA transplants using our current technique and instrumentation. Osteochondral grafts including MOPSTM OCAs are regulated under U.S. Food and Drug Administration (FDA) section 361 of the Public Health Service Act and 21 Code of Federal Regulation 1271 that defines human cells, tissues or cellular or tissue based products (HCT/P).
Patients will follow a managed post-operative rehabilitation protocol that is standard for those that have had an osteochondral allograft to their ankle.
Range of motion and patient-reported outcome measures (PROMs) including VAS pain score, AOFAS, and PROMIS Mobility as well as complete radiographs (XR) of the affected ankle will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery to evaluate healing, function and evidence for arthrosis. MRIs for cartilage composition (12 months after surgery, and serum and urine biomarkers for treatment monitoring (preop, 6 and 12 months after surgery) will be performed. We will document all adverse events and complications, including joint or incision infection, graft failure, hardware failure, and arthrofibrosis. Patients with a VAS pain score >5 beyond 3 months postoperatively or clinical or diagnostic imaging evidence for nonunion or graft collapse will undergo MRI of the ankle to determine the appropriate clinical course of action. OCA survival will be determined based on maintenance of acceptable levels of pain (<2 VAS) and function and/or need for revision surgery or total ankle arthroplasty, fusion, or amputation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-traumatic Ankle OA | – | Procedure: Osteochondral allograft anklePost-traumatic ankle OA and requiring osteochondral allograft to tibia and/or talus in ankle |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- With informed consent, patients (n=10) who require tibio-talar arthroplasty based on physical examination and diagnostic imaging will be enrolled. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the tibial plafond and/or talar dome as determined by physical examination, diagnostic imaging and/or arthroscopy by the attending surgeon. Exclusion criteria include acute injury to any other part of the affected lower extremity or inability to comply with the protocol.
Key inclusion criteria (1 listed)
- Grade IV changes in the articular cartilage of the tibial plafond and/or talar dome as determined by physical exam, diagnostic imaging, and/or arthroscopy by the attending surgeon ii. Between the age of 18-55
Key exclusion criteria (1 listed)
- Acute injury to any other part of the affected lower extremity ii. Inability to comply with protocol iii. BMI greater than 40 iv. The subject is either pregnant or a prisoner v. Currently involved in worker's compensation case at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteochondral allograft ankleOpen osteochondral allograft to replace the cartilage that is grade four on the tibia and/or talus | Procedure or surgery | Post-traumatic Ankle OA |
Primary outcome
Visual Analog Scale (VAS) score
Time frame: 12 Months
Pain assessment which measures what a patient rates their pain between 0 and 10, with 0 being no pain, and 10 being the most pain
2 secondary outcomes
American Orthopaedic Foot and Ankle Society (AOFAS) score
Time frame: 12 Months
PROMIS - Physical Function and Mobility
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Stannard, MD principal investigator
University of Missouri, Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Osteoarthritis of Ankle and Ankle Osteoarthritis, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) score (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.